Clinical Data Science Lead

Working in ICON Strategic Solutions is more than a job, it’s a calling for people who care and have passion for improving patients’ lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you.

Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity.

• Is recognized as an expert within the discipline and beyond, with peers within the same technical area in the business as well as other key business functions.
• Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
• Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
• Project management of all clinical data management related deliverables by ensuring adherence to planned time, cost and quality
• Execution of the clinical data collection strategy in accordance with client standards (Data Collection, SDTM (CDISC)) as applicable
• Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s).
• Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program
• Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams.
• Drives and leads the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills

You possess;

• Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 8 years
• Substantial project management experience
• Proficiency with data management systems such as InForm™, Rave or other industry electronic data capture systems and other systems such as ePRO, eHR, etc.
• Comprehensive knowledge of ICH-GCP and major health authorities (e.g. FDA, EMA, CFDA, PMDA) regulations
• CDISC fundamentals knowledge
• Knowledge of SAS, SQL or other programming languages
• Knowledge of medical terminology, Coding systems, SAE reconciliation
• Excellent knowledge of regulations and guidance about clinical development and the systems used in this context
• Leading teams in matrix environment